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Clovis Oncology, Evergreen Theragnostics Developing Actinium-225-Labeled Radionuclide

NEW YORK – Clovis Oncology has inked a deal with Evergreen Theragnostics to develop an actinium-225-labeled version of its radionuclide therapy FAP-2286, the company said on Wednesday.

The two companies will advance radiolabeling chemistry and analytical methods for future preclinical and clinical studies of 225Ac-FAP-2286. Evergreen will develop 225Ac-FAP-2286 at its Springfield, New Jersey, facility, which is designed for developing and manufacturing radiopharmaceuticals, such as those based on alpha-emitting isotopes like actinium-225. The companies didn't disclose the financial terms of the deal.

Boulder, Colorado-based Clovis is evaluating FAP-2286, the lead agent in its targeted radionuclide therapy program, in the Phase I/II LuMIERE study in patients with FAP-positive tumors. FAP-2286 is both a therapeutic and imaging agent based on how it is labeled.

The product contains a targeting peptide that binds to FAP, a protein that is highly expressed on cancer-associated fibroblasts. The targeting peptide labeled with gallium-68 serves as the imaging agent for identifying patients with FAP-positive tumors. Those patients can then receive FAP-2286 labeled with the radiometal lutetium-177.

The latest agreement with Evergreen will allow Clovis to expand the FAP-2286 program and assess the agent with another radioactive isotope, actinium-225. "This agreement with Evergreen Theragnostics represents an important step forward for Clovis in our efforts to optimize our clinical development program for FAP-2286," Clovis CEO and President Patrick Mahaffy said in a statement. "Actinium-225 represents an emerging radionuclide that is generating significant interest for its potential for therapeutic use."

Unlike lutetium-177, which is a beta particle-emitting radionuclide, actinium-225 is an alpha particle-emitting radionuclide with a half-life of around 10 days, a window that may provide advantages when it comes to centralized manufacturing and distribution to cancer centers treating patients with the agent. 225Ac-FAP-2286 will be designed to home in on FAP-expressing tumors and cause cell death through double-stranded DNA breaks, while sparing damage to surrounding tissues.